D7.1 Guidance for the interaction between HTD and HTA (for JCA and JSC)
Public consultation closed.
This EUnetHTA 21 deliverable (D7.1) focusses on the guidance for the interaction between HTA bodies and Health Technology Developer (HTD) during Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC).
The objectives of this deliverable are to:
- Produce a practical guidance for HTA/HTD interaction, by defining objectives and extent of interaction between HTA agencies and HTD for JCA and JSC.
- Define a process for handling commercially sensitive and academic in-confidence data.
- Create a procedure and framework for the factual accuracy check (if decided to continue this as a process step) if HTD have submitted a dossier.
- Update the Frequently Asked Questions and procedure manual of JA3 to increase awareness and understanding of the JCA procedures for HTD.
- Provide a definition of an incomplete Submission Dossier and outline a procedure for managing incomplete submissions.
Project Plan: D7.1 Guidance for the interaction between HTD and HTA (for JCA and JSC) – Project Plan
For any questions regarding this deliverable, please contact JCA_Secretariat@zinl.nl
Below you can find the published documentation: